OsteoarthritisNCT02246088
Neuroscience Education on Osteoarthritis
A study testing MT + NE and MT + E in people with Osteoarthritis, run by University of Valencia at 1 site in Spain.
Trial summary
Osteoarthritis (OA) is a frequent chronic musculoskeletal pathology that usually causes great disability and significant healthcare costs. Substantial scientific evidence indicates a role for central sensitization in OA pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- MT + NE and MT + E
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- An established diagnosis of knee OA according to American College of Rheumatology criteria and Kellgreen/Lawrence scale grades.
- To be in a waiting list and scheduled to undergo primary knee arthroplasty.
- To have sufficient Spanish language skills to comprehend all explanations and to complete the assessment tools.
Who cannot join
- Previous knee joint replacement surgery of the affected joint or any other lower limb surgery within the past 6 months.
- Stated inability to attend or complete the proposed course of intervention and follow-up schedule.
- Presence of co-morbidities associated with cognitive impairment.
- Co-existing inflammatory, metabolic, neurological or severe medical conditions, defined as a diagnosis in the medical record severe enough that the patient cannot participate fully in the study procedures (i.e. cardiovascular disease).
- Functional illiteracy.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de La Ribera
Alzira, Valencia, 46600
Enrique Lluch, PT
Luis Aguilella, PhD
About this study
Official title: Effect of Neuroscience Education on Subjects With Chronic Knee Pain Related to Osteoarthritis : a Randomized Controlled Trial
Osteoarthritis (OA) is a frequent chronic musculoskeletal pathology that usually causes great disability and significant healthcare costs. Substantial scientific evidence indicates a role for central sensitization in OA pain. Reconceptualization of pain through Neuroscience Education (NE) is an intervention that has already been used successfully in some chronic musculoskeletal pain conditions characterized by alteration on CNS pain processing or central sensitization (i.e. chronic low back pain, chronic fatigue syndrome, widespread pain and chronic whiplash associate disorders).There is compelling evidence that NE have a positive effect on pain, disability, catastrophization and physical performance for chronic musculoskeletal pain disorders, yet studies examining the value of NE for OA patients are essentially lacking.
The primary aim of this study is to assess the effect of NE on pain, disability and physical performance in subjects with chronic OA knee pain waiting for replacement surgery. This will be the first time NE will be addressed specifically to OA pain. To investigate the benefits of NE on pain related to knee OA, the effect of a manual therapy intervention combined with NE (MT+NE) will be compared with this same manual intervention plus an educational program based on a traditional patho-anatomical or biomedical model (MT+E). The following secondary aims will be addressed as well:
- Examining the effects of the two interventions on the mechanism of central sensitization in patients with knee OA;
- Examining the effects of the two interventions on pain catastrophizing, illness perceptions and kinesiophobia in patients with knee OA;
- Finally, it is aimed at identifying effect moderators for NE in patients with knee OA.
Read the detailed description
Osteoarthritis (OA) is a frequent chronic musculoskeletal pathology that usually causes great disability and significant healthcare costs. Substantial scientific evidence indicates a role for central sensitization in OA pain. Pathophysiological mechanisms underlying central sensitisation are complex and numerous, but the net effect is an amplification of neural signaling within the CNS than elicits pain hypersensitivity. Central sensitization management is an area of great interest at least in a subgroup of patients with OA pain.
Reconceptualization of pain through Neuroscience Education (NE) is an intervention that has already been used successfully in some chronic musculoskeletal pain conditions characterized by alteration on CNS pain processing or central sensitization (i.e. chronic low back pain, chronic fatigue syndrome, widespread pain and chronic whiplash associate disorders). Moreover, some clinical guides to help clinicians to identify and explain central sensitization through NE, have been recently published. However, this kind of intervention has never been tested specifically for chronic pain related to OA.
Preoperative education centered on a biomedical model of anatomy and pathoanatomy as well as procedural information has limited effect in reducing postoperative pain after total hip arthroplasty and total hip arthroplasty surgeries. Preoperative educational sessions that aim to increase patient knowledge of pain science (i.e. NE) may be more effective in managing postoperative pain. NE is a cognitive-based educational intervention that aims to reduce pain and disability by helping patients gain an increased understanding of the biological processes underpinning their pain state. There is compelling evidence that NE have a positive effect on pain, disability, catastrophization and physical performance for chronic musculoskeletal pain disorders, yet studies examining the value of NE for OA patients are essentially lacking.
Joint mobilization has been shown to be a useful modality to reduce pain related to osteoarthritis. Regarding the knee joint, two recent systematic reviews demonstrated the usefulness of manual therapy and exercise for the management of knee OA. Moreover, Deyle et al reported a preliminary clinical prediction rule which may help to identify the minority of knee OA patients who are unlikely to respond to this management approach.
The primary aim of this study is therefore to assess the effect of NE on pain, disability and physical performance in subjects with chronic OA knee pain waiting for replacement surgery. This will be the first time NE will be addressed specifically to OA pain. To investigate the benefits of NE on pain related to knee OA, the effect of a manual therapy intervention combined with NE (MT+NE) will be compared with this same manual intervention plus an educational program based on a traditional patho-anatomical or biomedical model (MT+E). The following secondary aims will be addressed as well:
- Examining the effects of the two interventions on the mechanism of central sensitization in patients with knee OA;
- Examining the effects of the two interventions on pain catastrophizing, illness perceptions and kinesiophobia in patients with knee OA;
- Finally, it is aimed at identifying effect moderators for NE in patients with knee OA.
- Conditions
- Osteoarthritis
- Being tested
- MT + NE, MT + E
- Keywords
- Osteoarthritis, Central Nervous System Sensitization
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT + NEProcedure or surgery
Manual therapy will be applied using mobilization with movement (MWM) techniques. MWM will consist of a sustained manual glide of the tibia (either medial, lateral, anterior, posterior, or rotation) during active knee flexion and extension, depending on which are the limited/painful movements for each patient.
The content and pictures of the neuroscience education (NE) will be based on the text "Explicando el dolor" (Spanish version of "Explain Pain").
MT + EProcedure or surgery
Program of education based on the traditional biomedical model (i.e. through visualization of several videos related to anatomy, biomechanics and surgical procedure of the knee), plus the same manual treatment as per the MT+NE group
| Study group | Role | What they receive |
|---|---|---|
| MT + NE | Experimental | A manual therapy (MT) intervention combined with neuroscience education (NE) Receives: Procedure: MT + NE |
| MT + E | Active comparator | Manual therapy (MT) intervention plus an educational program based on a traditional patho-anatomical or biomedical model (E) Receives: Procedure: MT + E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous analgesia through the experimental protocol of conditioned pain modulation
For assessing endogenous analgesia, the method examining the influence of the Diffuse Noxious Inhibitory Control system (or spatial summation) on temporal summation will be applied. Recently, the term conditioned pain modulation has been recommended to describe the psychophysical paradigm of Diffuse Noxious Inhibitory Control system in humans
Measured: Up to 3 months
Secondary outcomes (12)
Pain at rest and in the last 24 hours
Participants will be asked to rate their pain at rest and in the last 24 hours on a horizontal 100-mm visual analogue scale (VAS). The horizontal line anchors will be "no pain" and "worst imaginable pain". The VAS is a valid and reliable instrument compared with other pain rating scales and has been well established in clinical practice and research for measuring pain levels in arthritis populations.
Measured: Up to 3 months
Pressure Pain Thresholds
Local and distant sites will be chosen for pressure pain threshold measurement. Regarding local sites, two points will be measured from the knee, 3 cm medial and lateral to the midpoint of the medial and lateral edge of patella, respectively. Regarding control site, a distant site will be used to assess systematic analgesic effect of NE at 5 cm distal to lateral epicondyle.
Measured: Up to 3 months
Western Ontario and McMaster osteoarthritis index (WOMAC scale)
WOMAC assesses pain, stiffness and physical function and can be completed in less than 5 minutes. It's a widely used, reliable, valid and responsive measure of outcome in people with osteoarthritis of the hip or knee.
Measured: Up to 3 months
Health-related quality of life using the self-reported Spanish version SF-36 questionnaire
Measured: Up to 3 months
Tampa Scale of Kinesiophobia (TSK) (Spanish version)
Measured: Up to 3 months
Pain Catastrophization Scale (PCS) (Spanish version)
Measured: Up to 3 months
Chronic Pain Coping Inventory-42 (Spanish version)
Measured: Up to 3 months
Chronic Pain Acceptance Questionnaire (Spanish version)
Measured: Up to 3 months
Goniometric assessment of knee flexion and extension range of motion
Measured: Up to 3 months
Strength of the hamstrings and quadriceps muscles
Measured: Up to 3 months
Timed "Up & Go" (TUG) Test
Participants will be required to rise from a standard arm chair, walk at a safe and comfortable pace to a mark 3 m away and then return to a sitting position in the chair. The outcome of the test will be the time to complete the task. Time will be measured on a stopwatch to the nearest one-hundredth of a second.
Measured: Up to 3 months
Central Sensitization Inventory
Signs and symptoms suggesting central sensitization will be monitorized using the Central Sensitization Inventory
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de la Ribera
- Responsible party
- Principal investigator, Enrique Lluch Girbés, University of Valencia
- Investigators
- Enrique Lluch, PT, Principal investigator, University of ValenciaLuis Aguilella, PhD, Principal investigator, Hospital Universitario de la Ribera, Alcira (Valencia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246088
- Sponsor's protocol ID
- EDUART13
- Status last verified
- Sep 2014
- First submitted
- 15 Sep 2014
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lluch E, Torres R, Nijs J, Van Oosterwijck J. Evidence for central sensitization in patients with osteoarthritis pain: a systematic literature review. Eur J Pain. 2014 Nov;18(10):1367-75. doi: 10.1002/j.1532-2149.2014.499.x. Epub 2014 Apr 3.
PubMed 24700605Lluch Girbes E, Meeus M, Baert I, Nijs J. Balancing "hands-on" with "hands-off" physical therapy interventions for the treatment of central sensitization pain in osteoarthritis. Man Ther. 2015 Apr;20(2):349-52. doi: 10.1016/j.math.2014.07.017. Epub 2014 Aug 14.
PubMed 25169787Lluch Girbes E, Nijs J, Torres-Cueco R, Lopez Cubas C. Pain treatment for patients with osteoarthritis and central sensitization. Phys Ther. 2013 Jun;93(6):842-51. doi: 10.2522/ptj.20120253. Epub 2013 Feb 7.
PubMed 23392185Staud R. Evidence for shared pain mechanisms in osteoarthritis, low back pain, and fibromyalgia. Curr Rheumatol Rep. 2011 Dec;13(6):513-20. doi: 10.1007/s11926-011-0206-6.
PubMed 21833699Mease PJ, Hanna S, Frakes EP, Altman RD. Pain mechanisms in osteoarthritis: understanding the role of central pain and current approaches to its treatment. J Rheumatol. 2011 Aug;38(8):1546-51. doi: 10.3899/jrheum.100759. Epub 2011 Jun 1.
PubMed 21632678Lee YC, Nassikas NJ, Clauw DJ. The role of the central nervous system in the generation and maintenance of chronic pain in rheumatoid arthritis, osteoarthritis and fibromyalgia. Arthritis Res Ther. 2011 Apr 28;13(2):211. doi: 10.1186/ar3306.
PubMed 21542893Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.
PubMed 20418016Sofat N, Ejindu V, Kiely P. What makes osteoarthritis painful? The evidence for local and central pain processing. Rheumatology (Oxford). 2011 Dec;50(12):2157-65. doi: 10.1093/rheumatology/ker283. Epub 2011 Sep 27.
PubMed 21954151Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
PubMed 20961685Murphy SL, Lyden AK, Phillips K, Clauw DJ, Williams DA. Subgroups of older adults with osteoarthritis based upon differing comorbid symptom presentations and potential underlying pain mechanisms. Arthritis Res Ther. 2011 Aug 24;13(4):R135. doi: 10.1186/ar3449.
PubMed 21864381Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297-302. doi: 10.1016/s0004-9514(14)60169-0.
PubMed 12443524Moseley L. Unraveling the barriers to reconceptualization of the problem in chronic pain: the actual and perceived ability of patients and health professionals to understand the neurophysiology. J Pain. 2003 May;4(4):184-9. doi: 10.1016/s1526-5900(03)00488-7.
PubMed 14622702Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain. 2004 Sep-Oct;20(5):324-30. doi: 10.1097/00002508-200409000-00007.
PubMed 15322439Ryan CG, Gray HG, Newton M, Granat MH. Pain biology education and exercise classes compared to pain biology education alone for individuals with chronic low back pain: a pilot randomised controlled trial. Man Ther. 2010 Aug;15(4):382-7. doi: 10.1016/j.math.2010.03.003. Epub 2010 Mar 31.
PubMed 20359937Meeus M, Nijs J, Van Oosterwijck J, Van Alsenoy V, Truijen S. Pain physiology education improves pain beliefs in patients with chronic fatigue syndrome compared with pacing and self-management education: a double-blind randomized controlled trial. Arch Phys Med Rehabil. 2010 Aug;91(8):1153-9. doi: 10.1016/j.apmr.2010.04.020.
PubMed 20684894
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuroscience Education on Subjects With Chronic Knee Pain Related to Osteoarthritis : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02246088
- Acronym / sponsor ID
- EDUART13
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Central Nervous System Sensitization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital de la Ribera
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis (OA) is a frequent chronic musculoskeletal pathology that usually causes great disability and significant healthcare costs. Substantial scientific evidence indicates a role for central sensitization in OA pain. Reconceptualization of pain through Neuroscience Education (NE) is an intervention that has already been used successfully in some chronic musculoskeletal pain conditions characterized by alteration on CNS pain processing or central sensitization (i.e. chronic low back pain, chronic fatigue syndrome, widespread pain and chronic whiplash associate disorders).There is compelling evidence that NE have a positive effect on pain, disability, catastrophization and physical performance for chronic musculoskeletal pain disorders, yet studies examining the value of NE for OA patients are essentially lacking.
The primary aim of this study is to assess the effect of NE on pain, disability and physical performance in subjects with chronic OA knee pain waiting for replacement surgery. This will be the first time NE will be addressed specifically to OA pain. To investigate the benefits of NE on pain related to knee OA, the effect of a manual therapy intervention combined with NE (MT+NE) will be compared with this same manual intervention plus an educational program based on a traditional patho-anatomical or biomedical model (MT+E). The following secondary aims will be addressed as well:
- Examining the effects of the two interventions on the mechanism of central sensitization in patients with knee OA;
- Examining the effects of the two interventions on pain catastrophizing, illness perceptions and kinesiophobia in patients with knee OA;
- Finally, it is aimed at identifying effect moderators for NE in patients with knee OA.
Detailed description
Osteoarthritis (OA) is a frequent chronic musculoskeletal pathology that usually causes great disability and significant healthcare costs. Substantial scientific evidence indicates a role for central sensitization in OA pain. Pathophysiological mechanisms underlying central sensitisation are complex and numerous, but the net effect is an amplification of neural signaling within the CNS than elicits pain hypersensitivity. Central sensitization management is an area of great interest at least in a subgroup of patients with OA pain.
Reconceptualization of pain through Neuroscience Education (NE) is an intervention that has already been used successfully in some chronic musculoskeletal pain conditions characterized by alteration on CNS pain processing or central sensitization (i.e. chronic low back pain, chronic fatigue syndrome, widespread pain and chronic whiplash associate disorders). Moreover, some clinical guides to help clinicians to identify and explain central sensitization through NE, have been recently published. However, this kind of intervention has never been tested specifically for chronic pain related to OA.
Preoperative education centered on a biomedical model of anatomy and pathoanatomy as well as procedural information has limited effect in reducing postoperative pain after total hip arthroplasty and total hip arthroplasty surgeries. Preoperative educational sessions that aim to increase patient knowledge of pain science (i.e. NE) may be more effective in managing postoperative pain. NE is a cognitive-based educational intervention that aims to reduce pain and disability by helping patients gain an increased understanding of the biological processes underpinning their pain state. There is compelling evidence that NE have a positive effect on pain, disability, catastrophization and physical performance for chronic musculoskeletal pain disorders, yet studies examining the value of NE for OA patients are essentially lacking.
Joint mobilization has been shown to be a useful modality to reduce pain related to osteoarthritis. Regarding the knee joint, two recent systematic reviews demonstrated the usefulness of manual therapy and exercise for the management of knee OA. Moreover, Deyle et al reported a preliminary clinical prediction rule which may help to identify the minority of knee OA patients who are unlikely to respond to this management approach.
The primary aim of this study is therefore to assess the effect of NE on pain, disability and physical performance in subjects with chronic OA knee pain waiting for replacement surgery. This will be the first time NE will be addressed specifically to OA pain. To investigate the benefits of NE on pain related to knee OA, the effect of a manual therapy intervention combined with NE (MT+NE) will be compared with this same manual intervention plus an educational program based on a traditional patho-anatomical or biomedical model (MT+E). The following secondary aims will be addressed as well:
- Examining the effects of the two interventions on the mechanism of central sensitization in patients with knee OA;
- Examining the effects of the two interventions on pain catastrophizing, illness perceptions and kinesiophobia in patients with knee OA;
- Finally, it is aimed at identifying effect moderators for NE in patients with knee OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT + NE | Experimental | Procedure: MT + NEA manual therapy (MT) intervention combined with neuroscience education (NE) |
| MT + E | Active comparator | Procedure: MT + EManual therapy (MT) intervention plus an educational program based on a traditional patho-anatomical or biomedical model (E) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- An established diagnosis of knee OA according to American College of Rheumatology criteria and Kellgreen/Lawrence scale grades.
- To be in a waiting list and scheduled to undergo primary knee arthroplasty.
- To have sufficient Spanish language skills to comprehend all explanations and to complete the assessment tools.
Key exclusion criteria (5 listed)
- Previous knee joint replacement surgery of the affected joint or any other lower limb surgery within the past 6 months.
- Stated inability to attend or complete the proposed course of intervention and follow-up schedule.
- Presence of co-morbidities associated with cognitive impairment.
- Co-existing inflammatory, metabolic, neurological or severe medical conditions, defined as a diagnosis in the medical record severe enough that the patient cannot participate fully in the study procedures (i.e. cardiovascular disease).
- Functional illiteracy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT + NEManual therapy will be applied using mobilization with movement (MWM) techniques. MWM will consist of a sustained manual glide of the tibia (either medial, lateral, anterior, posterior, or rotation) during active knee flexion and extension, depending on which are the limited/painful movements for each patient. The content and pictures of the neuroscience education (NE) will be based on the text "Explicando el dolor" (Spanish version of "Explain Pain"). | Procedure or surgery | MT + NE |
| MT + EProgram of education based on the traditional biomedical model (i.e. through visualization of several videos related to anatomy, biomechanics and surgical procedure of the knee), plus the same manual treatment as per the MT+NE group | Procedure or surgery | MT + E |
Primary outcome
Endogenous analgesia through the experimental protocol of conditioned pain modulation
Time frame: Up to 3 months
For assessing endogenous analgesia, the method examining the influence of the Diffuse Noxious Inhibitory Control system (or spatial summation) on temporal summation will be applied. Recently, the term conditioned pain modulation has been recommended to describe the psychophysical paradigm of Diffuse Noxious Inhibitory Control system in humans
12 secondary outcomes
Pain at rest and in the last 24 hours
Time frame: Up to 3 months
Pressure Pain Thresholds
Time frame: Up to 3 months
Western Ontario and McMaster osteoarthritis index (WOMAC scale)
Time frame: Up to 3 months
Health-related quality of life using the self-reported Spanish version SF-36 questionnaire
Time frame: Up to 3 months
Tampa Scale of Kinesiophobia (TSK) (Spanish version)
Time frame: Up to 3 months
Pain Catastrophization Scale (PCS) (Spanish version)
Time frame: Up to 3 months
Chronic Pain Coping Inventory-42 (Spanish version)
Time frame: Up to 3 months
Chronic Pain Acceptance Questionnaire (Spanish version)
Time frame: Up to 3 months
Goniometric assessment of knee flexion and extension range of motion
Time frame: Up to 3 months
Strength of the hamstrings and quadriceps muscles
Time frame: Up to 3 months
Timed "Up & Go" (TUG) Test
Time frame: Up to 3 months
Central Sensitization Inventory
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
- Background: PubMed 24700605Lluch E, Torres R, Nijs J, Van Oosterwijck J. Evidence for central sensitization in patients with osteoarthritis pain: a systematic literature review. Eur J Pain. 2014 Nov;18(10):1367-75. doi: 10.1002/j.1532-2149.2014.499.x. Epub 2014 Apr 3.
- Background: PubMed 25169787Lluch Girbes E, Meeus M, Baert I, Nijs J. Balancing "hands-on" with "hands-off" physical therapy interventions for the treatment of central sensitization pain in osteoarthritis. Man Ther. 2015 Apr;20(2):349-52. doi: 10.1016/j.math.2014.07.017. Epub 2014 Aug 14.
- Background: PubMed 23392185Lluch Girbes E, Nijs J, Torres-Cueco R, Lopez Cubas C. Pain treatment for patients with osteoarthritis and central sensitization. Phys Ther. 2013 Jun;93(6):842-51. doi: 10.2522/ptj.20120253. Epub 2013 Feb 7.
- Background: PubMed 21833699Staud R. Evidence for shared pain mechanisms in osteoarthritis, low back pain, and fibromyalgia. Curr Rheumatol Rep. 2011 Dec;13(6):513-20. doi: 10.1007/s11926-011-0206-6.
- Background: PubMed 21632678Mease PJ, Hanna S, Frakes EP, Altman RD. Pain mechanisms in osteoarthritis: understanding the role of central pain and current approaches to its treatment. J Rheumatol. 2011 Aug;38(8):1546-51. doi: 10.3899/jrheum.100759. Epub 2011 Jun 1.
- Background: PubMed 21542893Lee YC, Nassikas NJ, Clauw DJ. The role of the central nervous system in the generation and maintenance of chronic pain in rheumatoid arthritis, osteoarthritis and fibromyalgia. Arthritis Res Ther. 2011 Apr 28;13(2):211. doi: 10.1186/ar3306.
- Background: PubMed 20418016Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.
- Background: PubMed 21954151Sofat N, Ejindu V, Kiely P. What makes osteoarthritis painful? The evidence for local and central pain processing. Rheumatology (Oxford). 2011 Dec;50(12):2157-65. doi: 10.1093/rheumatology/ker283. Epub 2011 Sep 27.
- Background: PubMed 20961685Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
- Background: PubMed 21864381Murphy SL, Lyden AK, Phillips K, Clauw DJ, Williams DA. Subgroups of older adults with osteoarthritis based upon differing comorbid symptom presentations and potential underlying pain mechanisms. Arthritis Res Ther. 2011 Aug 24;13(4):R135. doi: 10.1186/ar3449.
- Background: PubMed 12443524Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297-302. doi: 10.1016/s0004-9514(14)60169-0.
- Background: PubMed 14622702Moseley L. Unraveling the barriers to reconceptualization of the problem in chronic pain: the actual and perceived ability of patients and health professionals to understand the neurophysiology. J Pain. 2003 May;4(4):184-9. doi: 10.1016/s1526-5900(03)00488-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Lluch, PT principal investigator
University of Valencia
Luis Aguilella, PhD principal investigator
Hospital Universitario de la Ribera, Alcira (Valencia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MT + NE and MT + E in people with Osteoarthritis, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Aguilella, PhD (+34962458100, luis.aguilella@comv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endogenous analgesia through the experimental protocol of conditioned pain modulation (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02246088, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2014.